MORNING FRESH- sodium fluoride paste 
Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Toothpaste

Active Ingredient

Sodium Fluoride 0.22 %

Purpose: Anticavity

Use

Inactive Ingredient

Calcium carbonate, Carboxymethycellulose sodium, Flavour, Hydrated silica,Potassium nitrate,  Purified water, Saccharin sodium, Sodium benzoate, Sodium lauryl sulfate, Sorbitol

Dosage and Administration

Directions:

Indications and Usage

Warnings

Keep out of reach of children.

Keep out of reach of children under 6 years of age.

Principal Display Panel

Dynarex Morning Fresh Toothpaste

Morning Fresh.jpg

Morning Fresh

MORNING FRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-174-0143 g in 1 TUBE
2NDC:67777-174-0278 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/14/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2014
Document Id: ef3e3c40-6cd3-4f6f-a2c7-51ea1c64cf83
Set id: c9a46ade-abd3-4b3e-bd3a-cf689034daf4
Version: 1
Effective Time: 20140514
 
Dynarex Corporation